A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 2; peer review: 3 approved]
TBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clin...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Wellcome
2022-07-01
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| Series: | Wellcome Open Research |
| Subjects: | |
| Online Access: | https://wellcomeopenresearch.org/articles/6-280/v2 |
| _version_ | 1811344758967107584 |
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| author | Ronald B. Geskus Joseph Donovan Guy E. Thwaites Trinh Dong Huu Khanh |
| author_facet | Ronald B. Geskus Joseph Donovan Guy E. Thwaites Trinh Dong Huu Khanh |
| author_sort | Ronald B. Geskus |
| collection | DOAJ |
| description | TBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clinical trial (NCT03092817); ‘a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of HIV co-infected adults with tuberculous meningitis (TBM)’. The primary endpoint of the ACT HIV trial is death (from any cause) over the first 12 months after randomisation. This statistical analysis plan expands upon and updates the analysis plan outlined in the published study protocol. |
| first_indexed | 2024-04-13T19:52:45Z |
| format | Article |
| id | doaj.art-7b5d79d5dbbb44b3a37d96ca5135eff7 |
| institution | Directory Open Access Journal |
| issn | 2398-502X |
| language | English |
| last_indexed | 2024-04-13T19:52:45Z |
| publishDate | 2022-07-01 |
| publisher | Wellcome |
| record_format | Article |
| series | Wellcome Open Research |
| spelling | doaj.art-7b5d79d5dbbb44b3a37d96ca5135eff72022-12-22T02:32:27ZengWellcomeWellcome Open Research2398-502X2022-07-01619988A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 2; peer review: 3 approved]Ronald B. Geskus0https://orcid.org/0000-0002-2740-3155Joseph Donovan1https://orcid.org/0000-0002-5893-336XGuy E. Thwaites2https://orcid.org/0000-0002-2858-2087Trinh Dong Huu Khanh3Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, VietnamOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, VietnamOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, VietnamOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, VietnamTBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clinical trial (NCT03092817); ‘a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of HIV co-infected adults with tuberculous meningitis (TBM)’. The primary endpoint of the ACT HIV trial is death (from any cause) over the first 12 months after randomisation. This statistical analysis plan expands upon and updates the analysis plan outlined in the published study protocol.https://wellcomeopenresearch.org/articles/6-280/v2Tuberculous meningitis human immunodeficiency virus corticosteroids clinical trial analysis planeng |
| spellingShingle | Ronald B. Geskus Joseph Donovan Guy E. Thwaites Trinh Dong Huu Khanh A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 2; peer review: 3 approved] Wellcome Open Research Tuberculous meningitis human immunodeficiency virus corticosteroids clinical trial analysis plan eng |
| title | A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 2; peer review: 3 approved] |
| title_full | A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 2; peer review: 3 approved] |
| title_fullStr | A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 2; peer review: 3 approved] |
| title_full_unstemmed | A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 2; peer review: 3 approved] |
| title_short | A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial [version 2; peer review: 3 approved] |
| title_sort | statistical analysis plan for the adjunctive corticosteroids for tuberculous meningitis in hiv positive adults act hiv clinical trial version 2 peer review 3 approved |
| topic | Tuberculous meningitis human immunodeficiency virus corticosteroids clinical trial analysis plan eng |
| url | https://wellcomeopenresearch.org/articles/6-280/v2 |
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